Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases

NCT06978231 | Recruiting

• 1 other identifier: 2025SDU-QILU-3
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center randomized controlled trial. Eligible subjects meeting inclusion/exclusion criteria will be randomized 1:1 to EUS+ERCP group or ERCP group. Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. A comparative analysis was conducted to assess the impact of same-session EUS on ERCP strategy modification between two groups, utilizing a structured questionnaire.Secondarily, the safety and efficacy of same-session EUS will be comprehensively evaluated by comparing complication rates, technical success rate and hospitalization costs, length of stay, and radiation exposure between groups.

Conditions

Pancreaticobiilary Diseases

Outcome Measures

Primary Outcomes (1)

• ERCP strategy modification rate

  Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.

  From enrollment to 6 months after the end of treatment

Secondary Outcomes (4)

• Procedure outcomes

  From enrollment to 6 months after the end of treatment

• Incidence of complications

  From enrollment to 6 months after the end of treatment

• Radiation-related situation

  From enrollment to 6 months after the end of treatment

• Healthcare utilization measures

  From enrollment to 6 months after the end of treatment

Study Arms (2)

EUS+ERCP group

EXPERIMENTAL

EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.

Procedure: EUS+ERCP

ERCP group

OTHER

Only ERCP was performed in the control group

Procedure: ERCP

Interventions

EUS+ERCP PROCEDURE

EUS were performed during the same session with ERCP under continuous sedation/anesthesia

EUS+ERCP group

ERCP PROCEDURE

Only ERCP was performed in the control group

ERCP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years;
• Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
• No prior history of ERCP;
• No pancreaticobiliary EUS examinations within the preceding 3 months.

You may not qualify if:

• Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
• Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
• Patients with anatomical alterations or surgical history affecting EUS feasibility;
• Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
• Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
• Pregnancy or lactation;
• Patients with severe coagulopathy;
• Declined informed consent;
• Severe psychiatric disorder/non-cooperation precluding safe procedure.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Zhen Li, MD,PhD

CONTACT

+86 18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)